Validating the quality of manufacturing operations will become both more important and more difficult in years to come as, increasingly, drugs made in one part of the world are sold in another.
As a result, pharmaceutical firms wishing to sell in several markets must ensure their manufacturing facilities comply with standards set by a number of regulatory bodies, vastly increasing the complexity of validating operations.
GE’s approach to this problem is MVP, which combines scientific risk assessment, a comprehensive regulatory database and the automated generation of validation documents in a model that, it believes, is more flexible than the traditional validation masterplan (VMP) paradigm.
Victor Bornsztejn, GE’s global growth director, told in-PharmaTechnologist that: “A bulky VMP is difficult to write, review and maintain, making it difficult to control and subsequently close –out projects.”
Bornsztejn explained MVP had been developed to address not just this issue but the lack of standardisation and gaps between process development and facility design that many customers have raised as “problematic” aspects of validation.
“Furthermore, it was clear that the regulatory authorities were advocating improvements to the existing validation paradigms, but our customers, and many existing validation contractors, did not have the capacity, or were for various reasons unwilling, to drive these changes.
“We felt that there must be a way to accelerate this change through improved validation strategies, by leveraging information technology, and topping this off with a healthy dose of business process management and operational excellence methodologies.”
He also stressed GE’s desire to build long-term relationships with its customers, and suggested that an effective working relationship “means facilities can go on-line earlier and products can get onto the market quicker.”
Bornsztein said that one major drug company has already implemented MVP at an existing facility and added that but GE is in discussion with a variety of firms, ranging from biotech start-ups to Big Pharma, that have expressed an interest in the approach.